The standard approach: National voluntary consensus

Abstract

T he flight line is a busy place. It's important that lots of things be up to snuff in preparation for and during a mission. Part of the assurance that readiness will not be compromised is the knowledge that equipment and personnel meet necessary standards. These standards may be in the form of laws and regulations, industry and professional policies and procedures, or other directives or guidelines. The ability to properly provide air medical services includes adherence to all types of standards, but where do they come from? In many cases, government, either unilaterally or in collaboration with others, develops and adopts standards. Many ways exist to create standards, but none are easy. Some efforts are directed at achieving the gold standard, but in the absence of pre-existing thresholds, little room is left for consensus, and therefore difficulties may arise with adoption or acceptance. By first developing minimum standards, government creates a baseline from which to build toward higher levels of compliance. In the early 1980s, government development of EMS standards declined with the sunset of federally funded EMS grants. In response to Office of Management and Budget Circular A119, which first called for the voluntary consensus process, EMS leaders from across the nation met in Philadelphia in July 1984 to consider a new initiative. They decided to use a recognized organization to provide technical expertise in standards development. The 500 attendees agreed that this process would not be easy and that the road to success could be littered with the wreckage of many ideas and opinions. Many original parties have left the process, many others have joined, but the process continues. Some organizations thought they could do better on their own. However, this assumption was not always true. The organization selected to develop EMS guidelines, the American Society for Testing and Materials (ASTM), is one of the oldest and largest standards development systems in the world. Organized in 1898 to meet'the needs of the railroad and steel industries, ASTM has grown to include more than 33,000 technically qualified members who participate in 132 standardswriting committees in fields as diverse as plastics, metals, the e n vironment, energy, medical services and devices, electronics, and others. ASTM has created more than 10,000 standards, which are published and sold throughout the world and include specifications, test methods, standard guides, and practices. Each of these documents has been developed within the societ3/'s consensus principles, procedures, and regulations. Many factors contribute to the quality and credibili ty of ASTM standards, including a full voluntary consensus approach, a balanced representation of interests, and strict balloting and due process procedures that ensure technically competent standards with the highest credibility when critically examined and used as the basis for commercial, legal, or regulatory initiatives. ASTM standards become legally binding only when a government body makes them so or when they are cited in a contract. The U.S. Department of Transportation (DOT) has supported the process since its inception with grants and other initiatives. In 1997, the federal government amended the Technology Transfer Act to include the requirement that future standards development be based on voluntary consensus when new or revised standards are required. This mandate is designed not only to reduce the cost of government but also to broaden the inclusion of essential stakeholders in the process. ASTM Committees F-30 on Emergency Medical Services (chaired by Joseph Phillips, EMS director for the state of Tennessee), F-32 on Search and Rescue, and F-29 on Respiratory and Anesthesia Equipment include hundreds of members who, along with members of other ASTM committees, have developed more than 200 standards that affect the EMS community. These standards include documents that guide the organization and management of EMS systems, standards for communications programs, practices and equipment, operational and training standards, and standards for equipment, including a wide variety of biomedical devices and patient care and transportation equipment. This equipment ranges from resuscitators, airways, and oxygen systems to spine boards, collars, and even ground and air vehicles, including fixedand rotor-wing air transport units.